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The study was withdrawn due to protocol revision and scientific re-evaluation
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This study aims to develop and pilot a cloud-based Patient-Reported Outcomes (PROs) management program for home-based cancer pain patients within a hospital setting. It is expected to serve as a reference for improving pain management in home-based cancer care and to provide insights for future related research as well as the broader application and dissemination of the program.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | No Intervention | The control group received conventional telephone follow-up. Specifically, at 1 week and 3 weeks after discharge, ward follow-up nurses who had undergone standardized training conducted the follow-up using a pre-established checklist. The telephone calls covered pain intensity, location, medication usage, and adverse drug reactions. | |
| Intervention Group | Experimental | Prior to discharge, a nurse instructed patients on using the cloud-based follow-up platform. Patients then reported outcomes weekly via the platform using the PROMIS-29 profile. The system automatically monitored this data against preset thresholds; any exceedance triggered an alert to the care team for immediate assessment. Based on the reported data, the system also pushed personalized education on pain management and medication. Follow-up calls provided further guidance, including on non-pharmacological techniques to complement analgesic therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proactive monitoring and patient education | Other | The intervention featured proactive monitoring of PRO data with threshold-based alerts, coupled with personalized patient education via the cloud and follow-up calls, to enhance timely care and self-management. |
| Measure | Description | Time Frame |
|---|---|---|
| pain intensity | Use the Numerical Rating Scale (NRS) to assess pain intensity, with scores ranging from 0 to 10, where a higher number indicates more severe pain. | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Medication adherence | Morisky questionnaire on medication adherence, with scores ranging from 0 to 8; a higher score indicates better medication adherence. | 1 month |
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Inclusion Criteria:
Aged 18 years or older; Pathologically confirmed diagnosis of cancer with concomitant pain requiring analgesic medication; Alert and oriented, free of psychiatric disorders or cognitive impairment; Adequate comprehension, essentially normal vision and hearing, and basic literacy; Proficient in using a smartphone (patient or primary caregiver), willing to accept cloud-platform follow-up and participate throughout the study; Informed consent and voluntary participation.
Exclusion Criteria:
Presence of severe psychiatric disorders; Critically ill or debilitated patients with advanced-stage tumor who are unable to complete the study procedures.
Withdrawal Criteria:
Voluntary withdrawal or failure to complete the entire study process; Death during follow-up; Occurrence of accidents or clinical deterioration rendering continued participation infeasible; Request to withdraw for any reason.
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| Name | Affiliation | Role |
|---|---|---|
| Huafang Zhang, MSN | 4th Affiliated Hospital, School of Medicine, Zhejiang University, China | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 4th Affiliated Hospital, School of Medicine | Yiwu | Zhejiang | 32200- | China |
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| ID | Term |
|---|---|
| D000072716 | Cancer Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D010353 | Patient Education as Topic |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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